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SUPPORTED by GUIDELINES Clinical Practice Guidelines Recommend PCC Over Plasma to Reverse the Effects of Warfarin

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SUPPORTED by GUIDELINES Clinical Practice Guidelines Recommend PCC Over Plasma to Reverse the Effects of Warfarin Kcentra®, Prothrombin Complex Concentrate (Human), is the only FDA-approved alternative to plasma for urgent warfarin reversal SUPPORTED BY GUIDELINES Clinical Practice Guidelines Recommend PCC Over Plasma to Reverse the Effects of Warfarin Neurocritical Care Society and Society of Critical Care Medicine – 20161 “Benefits of PCC include its fast preparation and reconstitution time, rapid INR reversal, small volume, and lower risk of infection as compared to [plasma].” “PCC use in VKA-associated intracranial hemorrhage leads to faster INR reversal, less hematoma expansion, and similar or better mortality rates and functional outcomes compared to [plasma].” American College of Cardiology – 20172 “[For patients with VKA-associated major bleeding], administration [of vitamin K] must be accompanied by a repletion strategy (PCCs or plasma only if 4-factor PCC…is unavailable)…PCC can be given in a much smaller volume and at a much faster infusion rate…compared with plasma and is preferred.” American College of Chest Physicians – 20123 “For patients with VKA-associated major bleeding, we suggest rapid reversal of anticoagulation with [4-factor PCC] rather than with plasma.” American Society for Gastrointestinal Endoscopy – 20164 “For warfarin…reversal, the 4-factor PCC is the appropriate reversal agent.” American College of Surgeons – 20185 “[For elderly patients with TBI,] aggressive and early reversal of anticoagulant therapy may improve outcome. This result may be accomplished rapidly with the use of [PCC], plasma, and vitamin K.” American Society of Hematology – 20186 “For life-threatening bleeding during VKA treatment for VTE with an elevated INR, ASH suggests using 4-factor PCC and IV vitamin K rather than FFP.” INR, international normalized ratio; PCC, prothrombin complex concentrate; TBI, traumatic brain injury; VKA, vitamin K antagonist. Indications Kcentra is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only. Please see Important Safety Information including boxed warning, continued inside, and accompanying full Prescribing Information for Kcentra. Kcentra dosing is based on pretreatment INR and body weight Administer Kcentra for urgent reversal PRETREATMENT 2 to <4 4 to 6 >6 of warfarin-related acute major bleeding INR Dosea of Kcentra (unitsb of factor IX) 25 35 50 per kg body weight Maximum dosec Not to exceed Not to exceed Not to exceed (units of factor IX) 2500 3500 5000 aDosing is based on body weight. Dose based on actual potency is stated on the vial, which will vary from ASSESS AND IDENTIFY SEVERITY OF BLEED2 20 to 31 factor IX units/mL after reconstitution. The actual potency for a 500-unit vial ranges from 400 to 620 units/vial. The actual potency for a 1000-unit vial ranges from 800 to 1240 units/vial. bUnits refer to international units (IU). Bleed is considered major if ≥1 of the cDose is based on body weight up to but not exceeding 100 kg. For patients who weigh more than 100 kg, following apply: the maximum dose should not be exceeded. • Bleeding is at a critical site Administration of Kcentra according to a prospective, randomized, 7,a • Hemodynamic instability open-label, active-controlled, multicenter, noninferiority trial • Clinically overt bleeding with hemoglobin decrease ≥2 g/dL or administration of ≥2 units of RBCs TIME Start of End of 0.5 h after 24 h after start Kcentra end of Kcentra b infusion infusionb infusion of infusion Kcentra + Is the bleed at a critical site vitamin K Assessment of or is it life-threatening? (mean=24 rapidc INR reduction minutes) NO YES End of 0.5 h after plasma end of plasma infusionb infusion Stop warfarin Stop warfarin Plasma + vitamin K Assessment of (mean=169 minutes) rapidc INR reduction Initiate appropriate measures Initiate appropriate measures to control bleeding to control bleeding Assessment of hemostatic efficacy The relationship between these or other INR values and clinical hemostasis in patients has not been established. aTwo hundred twelve patients ≥18 years of age had acute major bleeding, were receiving warfarin, and had an elevated INR ≥2 within 3 hours before study treatment. bDuration varied between and within treatment groups. Administer Kcentra and c Did the above measures Thirty minutes after end of infusion. NO vitamin K to control bleeding control bleeding? and stabilize patient Important Safety Information (cont’d) Follow appropriate dosing and administration WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS Patients being treated with Vitamin K antagonist therapy have underlying disease states Adapted from Tomaselli GF et al (2017). that predispose them to thromboembolic events. Potential benefits of reversing VKA should RBC, red blood cell. be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, Please see Important Safety Information including boxed cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe warning, continued on the right, and accompanying full peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for Prescribing Information for Kcentra. patients with thromboembolic events in the prior 3 months. KCT-0227-MAR19 Kcentra.com CSLBehring.com King of Prussia, PA 19406-0901, USA 19406-0901, PA Prussia, of King 1020 First Avenue, PO Box 61501 Box PO Avenue, First 1020 2019 CSL Behring LLC Behring CSL 2019 © is a registered trademark of CSL Behring LLC. Behring CSL of trademark registered a is Life for Biotherapies ® is a registered trademark of CSL Behring GmbH. Behring CSL of trademark registered a is Kcentra ® Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Behring CSL by distributed and GmbH Behring CSL by manufactured is Kcentra American Association of Blood Banks; 2013. Banks; Blood of Association American Bethesda, MD: Bethesda, Components. Blood and Blood Human of Use the for Information of Circular Banks. Blood of Association American 8. antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. IIIb phase plasma-controlled, randomized, a bleeding: major with presenting antagonists 2013;128(11):1234-1243. Circulation. 7. 3291. Srd ,MligT,Rfa A ta.Efcc n aeyo -atrpohobncmlxcnetaei ainso iai K vitamin on patients in concentrate complex prothrombin 4-factor a of safety and Efficacy al. et MA, Refaai TJ, Milling R, Sarode . 2018;2(22):3257- . Adv Blood therapy. anticoagulation of management optimal thromboembolism: venous of management for guidelines Witt DM, Nieuwlaat R, Clark NP, et al. American Society of Hematology 2018 Hematology of Society American al. et NP, Clark R, Nieuwlaat DM, Witt 6. 2018. Surgeons; of College American IL: Chicago, ed. 10th Advanced Trauma Life Support (ATLS) Student Course Manual. Course Student (ATLS) Support Life Trauma Advanced Surgeons. of College American 5. 2016;83(1):3-16. Endosc. Gastrointest Practice Committee, Acosta RD, Abraham NS, et al. The management of antithrombotic agents for patients undergoing GI endoscopy. GI undergoing patients for agents antithrombotic of management The al. et NS, Abraham RD, Acosta Committee, Practice American Society for Gastrointestinal Endoscopy (ASGE) Standards of Standards (ASGE) Endoscopy Gastrointestinal for Society American 4. suppl):e152S-e184S. 2012;141(2 Chest. guidelines. practice therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical evidence-based Physicians Chest of College American ed: 9th Thrombosis, of Prevention and Therapy Antithrombotic therapy: Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant of management Evidence-based al. et DM, Witt S, Schulman A, Holbrook 3. 2017;70(24):3042-3067. Cardiol. Coll Am J in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on Expert Consensus Decision Pathways. Decision Consensus Expert on Force Task Cardiology of College American the of report a anticoagulants: oral on patients in 2. 2016;24(1):5-46. Tomaselli GF, Mahaffrey KW, Cuker A, et al. 2017 ACC expert consensus decision pathway on management of bleeding of management on pathway decision consensus expert ACC 2017 al. et A, Cuker KW, Mahaffrey GF, Tomaselli a statement for healthcare professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Care Critical of Society and Society Care Neurocritical the from professionals healthcare for statement a Neurocrit Care. Neurocrit Frontera JA, Lewin JJ III, Rabinstein AA, et al. Guideline for reversal of antithrombotics in intracranial hemorrhage: intracranial in antithrombotics of reversal for Guideline al. et AA, Rabinstein III, JJ Lewin JA, Frontera 1. References:
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